1. © The Johns Hopkins University and The Johns Hopkins Health System Corporation, 2011 CUSP for VAP: EVAP NHSN VAE Surveillance Definition Review Presented by: Kathleen Speck, MPH August 23, 2012 Armstrong Institute for Patient Safety and Quality

2. CUSP for VAP: EVAP Project Overview NIH/NHLBI and AHRQ funded project –Individual hospitals participate for 3 years, including 2 year intervention period and 1 year evaluation of sustainability Leveraging leaders in field –Armstrong Institute for Patient Safety and Quality, NIH/NHLBI, CDC, AHRQ, University of Pennsylvania, MHA and HAP 2 NIH/NHLBI - National Institutes of Health, National Heart, Lung, and Blood Institute; AHRQ - Agency for Healthcare Research and Quality

3. Our Collaborators – Karol G. Wicker, MHS Senior Director, Quality Policy & Advocacy Maryland Hospital Association kwicker@mhaonline.org –Mary Catanzaro RN BSMT CIC Project Manager HAIs Hospital and Healthsystem Association of Pennsylvania mcatanzaro@haponline.org 3

4. Who can join CUSP for VAP: EVAP? Participation in the program is available to any facility with mechanically ventilated patients in Maryland and Pennsylvania. Hospital participation will be coordinated with state hospital association or hospital engagement network (HEN). Armstrong Institute for Patient Safety and Quality 4

5. Learning Objectives To become more comfortable with the new VAE surveillance definitions To become familiar with a linelist generation tool and workbook developed by Michael Klompas, MD, MPH, FRCPC Armstrong Institute for Patient Safety and Quality 5

6. History of NHSN VAE Surveillance Definition Current NHSN VAP surveillance definition –Subjective Not sensitive or specific 1-3 Requires radiographic findings – often unclear Requires clinical signs and symptoms Doesn’t allow accurate validation of success of prevention strategies 4-7 Doesn’t allow establishment of valid benchmarks 6 1.Klompas M, JAMA 2002 2.Klompas M, Am J Infect Control 2010 3.Klompas M, et al, Clin Infect Dis 2008 4.Zilberberg MD, et al, Clin Infect Dis 2010 5.Girard T, et al, Lancet 2008 6.Strom T, et al, Lancet 2010 7.The Acute Respiratory Distress Syndrome Network, N Engl J Med 2000

7. Development of new VAE Surveillance Definition Working group – 2011 –Critical Care Societies Collaborative –American Association for Respiratory Care –Association of Professionals in Infection Control and Epidemiology –Council of State and Territorial Epidemiologists –Healthcare Infection Control Practices Advisory Committee’s Surveillance Working Group –Infectious Diseases Society of America –Society for Healthcare Epidemiology of America Armstrong Institute for Patient Safety and Quality 7

8. NHSN VAE Definition Objective Streamlined Potentially automatable Will define a broad range of conditions and complications occurring in mechanically ventilated patients Armstrong Institute for Patient Safety and Quality 8

9. Which locations should use VAE surveillance? 8 Inpatient –Acute care hospitals –Long term care hospitals –Rehabilitation facilities Unit type (examples) –Critical/intensive care units –Specialty care units –Step-down units –Long term care units Armstrong Institute for Patient Safety and Quality 9

10. Inclusions and Exclusions for VAE Surveillance in 2012 -2013 8 Excluded patients: –< 18 years of age –on high frequency ventilation or extracorporeal life support Included patients: –≥ 18 years of age –Receiving conventional mode of mechanical ventilation while prone or while receiving nitric oxide or epoprontenal therapy –On APRV or related therapy Use changes in PEEP only Armstrong Institute for Patient Safety and Quality 10

11. OTHER VAE ASSOCIATED DEFINITIONS 8

12. VAE Definition Tiers 8 12

13. NHSN Surveillance 2012-2013 Assessment must take place for all VAE tiers –VAC - Ventilator-associated Condition –IVAC - Infectious Ventilator-associated Condition –Possible VAP – Possible Ventilator- associated Pneumonia –Probable VAP – Probable Ventilator- associated Pneumonia Armstrong Institute for Patient Safety and Quality 13

14. VAC Definition Criteria 8 Patient intubated for > 2 calendar days Baseline stability –Baseline time period: The 2 calendar days immediately preceding the first day of increased daily minimum PEEP or FiO2 –Stability: The same 2 calendar days with stable or decreasing daily minimum PEEP or FiO2 Armstrong Institute for Patient Safety and Quality 14

15. Example - VAC Armstrong Institute for Patient Safety and Quality 15

16. Example – no VAC Armstrong Institute for Patient Safety and Quality 16

17. Subsequent VAEs The time period for a VAE is 14 days –Starts on day 1 of worsening oxygenation –New VAE cannot be reported until 14 day period has elapsed Armstrong Institute for Patient Safety and Quality 17

18. Episode of Mechanical Ventilation A period of days during which the patient is mechanically ventilated for at least a portion of each day. Armstrong Institute for Patient Safety and Quality 18

19. New Antimicrobial Agent Any agent listed in the Appendix of the Device Associated Events: VAE (pages 10-19 through 10-21) that: –Is initiated on or after the third day of mechanical ventilation AND –is given in the 5 day period defined by 2 days before the day of the 2 days after AND –Was not given to the patient on either of the two days preceding the current start date Armstrong Institute for Patient Safety and Quality 19

20. Date of Event The date of onset of worsening oxygenation –First calendar day in which minimum PEEP and FiO2 increases above thresholds in the VAE algorithm Armstrong Institute for Patient Safety and Quality 20

21. DETERMINATION OF A VAE

22. VAE Outcomes VAE = VAC, IVAC, Possible VAP and Probable VAP VAC = Significant respiratory deterioration after 2 or more days of stability IVAC = VAC + abnormal temp or WBC + ≥ 4 days of new antibiotics Possible VAP = IVAC + purulent sputum or positive sputum/BAL culture Probable VAP = IVAC + purulent sputum AND positive sputum/BAL culture Armstrong Institute for Patient Safety and Quality 22

23. Setting Up a Linelist Armstrong Institute for Patient Safety and Quality 23

24. Linelist Generator, developed by Michael Klompas, MD, MPH, FRCPC Will help you apply the new CDC VAE criteria Will automatically flag VAC, IVAC, possible VAP and probable VAP Armstrong Institute for Patient Safety and Quality 24

25. Linelist Definitions Armstrong Institute for Patient Safety and Quality 25

26. Steps to generate linelist for VAE Begin with “Daily Linelist” Enter patient identifier, date, daily minimum PEEP and FiO2 for every ventilated patient for every calendar day the patient spends any time on a ventilator Worksheet will automatically flag events that fulfill criteria for VAC If a patient is not identified as having VAC, don’t collect any further information for that patient. Armstrong Institute for Patient Safety and Quality 26

27. Determination of VAC After period of stability or improvement on the ventilator the patient has at least one of these indicators of worsening oxygenation –Daily min FiO2 values increase ≥ 0.20 over daily min for preceding 2 calendar days –Daily min PEEP values increase ≥ 3 cm H 2 O over daily min for the preceding 2 calendar days Armstrong Institute for Patient Safety and Quality 27

28. Step 1 – VAC Armstrong Institute for Patient Safety and Quality 28

29. Determination of IVAC Only look at patients where VAC has been determined Enter: –Tmin and Tmax –WBCmin and WBCmax –QAD – Qualifying antibiotic day IVAC requires 4 contiguous days of a new antibiotic starting within the 5 days starting 2 days before the onset Armstrong Institute for Patient Safety and Quality 29

30. Step 2 - IVAC Armstrong Institute for Patient Safety and Quality 30

31. Determination of Possible VAP or Probable VAP Only look at patients where IVAC has been determined From Sputum of BAL gram stain –Enter Polys – polys, neutrophils or WBC (semiquantitative scale) Epis – epithelial cells or squamous cells (semiquantitative scale) Culture – result Quantity - threshold (10^5 for endotracheal aspirate, 10^4 for BAL, 10^3 for protected specimen brush). Semi-quantitative equivalent also acceptable. Answer Yes or No. Armstrong Institute for Patient Safety and Quality 31

32. Semiquantitative Scale for Polys and Epis Armstrong Institute for Patient Safety and Quality 32 NoneEnter 0 Few, rare, ≤10 cells/lpfEnter 1 Moderate, ≥25 cells/lpfEnter 2 ManyEnter 3 AbundantEnter 4

33. Step 3 – Possible VAP or Probable VAP Armstrong Institute for Patient Safety and Quality 33

34. NHSN Event Report 1 st Page (Top) - Patient Information Armstrong Institute for Patient Safety and Quality 34

35. NHSN Event Report 1 st (Bottom)Page – Event Details Armstrong Institute for Patient Safety and Quality 35

36. Next Steps If your hospital is participating in this project, you will be receiving –Draft CDC Device-associated Events – VAE manual –Draft revised VAE reporting form –Dr. Klompas’ worksheet for VAE Linelist generation Next week – Q & A on CDC reporting manual and reporting form Armstrong Institute for Patient Safety and Quality 36

37. Enrollment If your hospital is not participating in the project and you are interested, please contact your hospital association representative – Karol G. Wicker, MHS Senior Director, Quality Policy & Advocacy Maryland Hospital Association kwicker@mhaonline.org –Mary Catanzaro RN BSMT CIC Project Manager HAIs Hospital and Healthsystem Association of Pennsylvania mcatanzaro@haponline.org 37

38. Questions? Armstrong Institute for Patient Safety and Quality 38

39. References 39 1.Klompas M. Does this patient have ventilator-associated pneumonia? Jama 2007 Apr 11;297(14):1583-93. 2.Klompas M. Interobserver variability in ventilator-associated pneumonia surveillance. Am J Infect Control. 2010 Apr;38(3):239-9. Epub 2010 Feb 19. 3.Klompas M, Kulldorf M, Platt R. Risk of misleading ventilator-associated pneumonia rates with use of standard clinical and microbiological criteria. Clin Infect Dis. 2008 May 1;46(9):1443-6. 4.Zilberberg MD, Shorr AF. Ventilator-associated pneumonia: the clinical pulmonary infection score as a surrogate for diagnostics and outcome. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S131-5. 5.Girard TC, Kress JP, Fuchs BD, Thomason JW, Schweikert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard DR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomized controlled trial. Lancet. 2008 Jan 12;371(9607):126-34.

40. References 40 6.Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomized controlled trial. Lancet. 2010 Feb 6;375(9713):475-80. Epub 2010 Jan 29. 7.The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. 8.Draft – CDC Device-associated Events VAE, Ventilator-Associated Event. 9.Klompas M. Linelist Generator Workbook. Not published.